SPL v1
SPL
SPL Set ID 41623a46-e6e7-907e-e063-6394a90afc4c
Route
TOPICAL
Published
Effective Date 2026-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol Glucuronide (6 g) Histamine (0.025 g) Camphor (synthetic) (3 g) Capsaicin (12 g) Salicylic Acid
Inactive Ingredients
Cetyl Esters

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-01

Description

Methyl Salicylate 12% Menthol USP 6% Camphor USP 3% Capsaicin 0.025% Histamine Dihydrochloride 0.025%

Purpose

Purpose External Analgesic


Medication Information

Purpose

Purpose



External Analgesic

Description

Methyl Salicylate 12% Menthol USP 6% Camphor USP 3% Capsaicin 0.025% Histamine Dihydrochloride 0.025%

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains

Warnings

For external use only. Do not use if allergic to salicylates (including aspirin), on wounds or damaged skin or with a heat source. When using this product: avoid bandaging tightly, avoid contact with eyes, keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away.

Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.

Questions

1-800-225-3963

Directions

Directions: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.

Inactive Ingredients

Inactive Ingredients: Aloe Barbadensis Leaf Extract, Carbomer, Cetearyl Alcohol, Cetyl Esters, Caprylyl Glycol, Glycerin, Phenoxyethanol, Polysorbate 60, Purified Water, Sodium Carbonate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Yucca Schidigera Stem Extract.

Keep Out of Reach of Children

Keep out of reach of children, if swallowed get medical help or contact a Posion Control Center right away.

Active Ingredients Section Otc

Methyl Salicylate 12%

Menthol USP 6%

Camphor USP 3%

Capsaicin 0.025%

Histamine Dihydrochloride 0.025%

Sombra Max Package Label Principal Display Panel


Structured Label Content

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains

Purpose

Purpose



External Analgesic

Warnings

For external use only. Do not use if allergic to salicylates (including aspirin), on wounds or damaged skin or with a heat source. When using this product: avoid bandaging tightly, avoid contact with eyes, keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away.

Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.

Questions

1-800-225-3963

Directions

Directions: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.

Inactive Ingredients

Inactive Ingredients: Aloe Barbadensis Leaf Extract, Carbomer, Cetearyl Alcohol, Cetyl Esters, Caprylyl Glycol, Glycerin, Phenoxyethanol, Polysorbate 60, Purified Water, Sodium Carbonate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Yucca Schidigera Stem Extract.

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children, if swallowed get medical help or contact a Posion Control Center right away.

Active Ingredients Section Otc (Active Ingredients Section OTC)

Methyl Salicylate 12%

Menthol USP 6%

Camphor USP 3%

Capsaicin 0.025%

Histamine Dihydrochloride 0.025%

Sombra Max Package Label Principal Display Panel


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)